Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Information source: Centro per le Malattie Tropicali
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Strongyloidiasis
Intervention: Ivermectin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Centro per le Malattie Tropicali Overall contact:
Dora Buonfrate, MD, Phone: +39 601 3563, Email: dora.buonfrate@sacrocuore.it
Summary
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single
dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be
fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to
eradicate the parasite.
Aim of this study is to define the most effective dose schedule of ivermectin to cure
strongyloidiasis.
Clinical Details
Official title: Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: clearance of strongyloides infection
Secondary outcome: All-cause mortality during the 12 months of follow-up.Patients with partial response to treatment at T 2 Patients with adverse reactions Patients with increase in blood ALT over cutoff value Patients with decrease in WBC count below cutoff value Average difference in blood ALT and WBC count at day 17, compared with baseline Average difference in blood eosinophil count at T2, compared with baseline
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients older than 5 years and weighting > 15 kg
- Current residence in non-endemic areas
- Either direct diagnosis of S. stercoralis infection AND positive serology at any
titer OR positive serology at "high" titer, irrespective of results of direct tests
Exclusion Criteria:
- Pregnant or lactating women
- Subjects suffering from CNS diseases
- Disseminated strongyloidiasis
- Immunocompromised patients.
- Lack of informed consent
- Previous treatment with ivermectin (in the last year)
Locations and Contacts
Dora Buonfrate, MD, Phone: +39 601 3563, Email: dora.buonfrate@sacrocuore.it
IMTA, Antwerp, Belgium; Not yet recruiting
Clinica di Malattie Infettive e Tropicali, Brescia, Italy; Recruiting
UFDID, Azienda Ospedaliero-universitaria Careggi, Florence, Italy; Recruiting
Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital, Florence, Italy; Active, not recruiting
Reparto Malattie Infettive, Ospedale Ca' Foncello, Treviso, Italy; Active, not recruiting
UPCH, Hospital Cayetano Heredia, Lima, Peru; Not yet recruiting
FCRB, Hospital Clinic de Barcelona, Barcelona, Spain; Active, not recruiting
Unitat Medicina Tropical i Salut Internacional Drassanes, Barcelona, Spain; Not yet recruiting
UCLH, London, United Kingdom; Active, not recruiting
Unidad de Medicina, Hospital de Poniente-El Ejido, El Ejido, Almeria, Spain; Recruiting
Joaquin Salas Coronas, Principal Investigator
Centro per le Malattie Tropicali, Ospedale Sacro Cuore, Negrar, Verona 37024, Italy; Recruiting
Additional Information
Starting date: March 2013
Last updated: January 20, 2014
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